One-quarter of the government shut down early Saturday, and as the partial shutdown is expected to continue into the new year, several federal agencies will be impacted, including the FDA.
As funding for several federal agencies expired at midnight on Friday, a partial government shutdown began on Saturday and is expected to continue into the new year. While most of HHS, including the National Institutes of Health and the CDC, is already funded through 2019, other agencies will be impacted.
Beginning today, 41% of the FDA will be furloughed, with the majority of the agency considered essential or funded by user fees paid for by the drug and device industry.
On Friday, when it became clear that the shutdown was nearing, FDA Commissioner Scott Gottlieb, MD, tweeted: “I recognize the consequences of a federal shutdown to the public we serve, our employees and their families—especially during this holiday season. I know the burdens will intensify the longer there is a lapse in funding and I am doing everything possible to ease the impact.”
According to a contingency plan released by HHS, the FDA will continue specific activities within the scope of its user fee—funded programs, including those for prescription drugs, generic drugs, biosimilars, medical devices, and tobacco products. Existing critical public health challenges, including drug shortages and outbreaks related to foodborne illness and infectious diseases, will continue to be addressed.
The agency will also continue to respond to emergencies, manage high-risk recalls, pursue criminal enforcement work and civil investigations related to imminent threats to human health or life, review important entries to determine potential risks to health, and respond to other critical public health issues, as appropriate.
However, the FDA will be unable to support certain routine regulatory and compliance activities, including some medical product—related and most food-related activities.
According to STAT News, the shutdown will also effectively end a bipartisan effort to pass a piece of public health legislation that would help the government respond to public health emergencies. The legislation would reauthorize the 2006 Pandemic and All Hazards Preparedness Act, which allows the government to fund various programs that respond to health-related emergencies and helps the government work with private companies to develop medical technology for those emergencies, such as vaccines.
Various healthcare stakeholders have responded to the partial shutdown, including the American Public Health Association (AHPA).
“The administration and Congress’s inability to approve funds to keep the federal government open is unacceptable ad poses a threat to public health. This shutdown is a political failure, and AHPA urges the government to put ideology aside and reach a funding solution as soon as possible,” said Georges C. Benjamin, MD, executive director, APHA, in a statement.
Dr Kathy Zackowski Discusses the Importance of Rehabilitation Research and Trials in MS
April 26th 2024Kathy Zackowski, PhD, National MS Society, expresses the inherent value of quality rehabilitation trials for broadening clinical understandings of multiple sclerosis (MS) and bettering patient outcomes.
Read More
Examining Low-Value Cancer Care Trends Amidst the COVID-19 Pandemic
April 25th 2024On this episode of Managed Care Cast, we're talking with the authors of a study published in the April 2024 issue of The American Journal of Managed Care® about their findings on the rates of low-value cancer care services throughout the COVID-19 pandemic.
Listen
Empowering Community Health Through Wellness and Faith
April 23rd 2024To help celebrate and recognize National Minority Health Month, we are bringing you a special month-long podcast series with our Strategic Alliance Partner, UPMC Health Plan. In the third episode, Camille Clarke-Smith, EdD, MS, CHES, CPT, discusses approaching community health holistically through spiritual and community engagement.
Listen
Kaiser Permanente was hit by a data breach in mid-April, impacting 13.4 million health plan members; GlaxoSmithKline (GSK) sued Pfizer and BioNTech for allegedly infringing on its messenger RNA technology patents in the companies’ COVID-19 vaccines; the CDC announced the first-known HIV cases transmitted via cosmetic injections.
Read More